Aerosol delivery systems

ABSTRACT

There is provided an electronically controlled, motor-driven, breath actuated metered dose inhaler for delivering aerosolized medicament or other matter to a user. The inhaler may comprise a base housing including a motor-driven actuator and other system components and a removable aerosol cartridge insertably receivable in the base housing. The inhaler may be paired with a smart phone or other client computing device to provide additional functionality, such as to provide instructional information and feedback regarding usage of the inhaler, to generate and display dosage tracking information, and to provide alerts and reminders to a user of the inhaler or others.

BACKGROUND Technical Field

This disclosure generally relates to aerosol delivery systems andrelated methods, and, more particularly, to aerosol delivery unitssuitable for selectively delivering a dose of aerosolized matter forinhalation by a user.

Description of the Related Art

It is well known to treat patients with medicaments contained in anaerosol, for example, in the treatment of respiratory disorders. It isalso known to use for such treatment, medicaments which are contained inan aerosol and are administered to a patient by means of an inhalationdevice comprising a mouthpiece and a housing in which an aerosolcanister is loaded. Such inhalation devices are generally referred to asmetered dose inhalers (MDIs). The aerosol canisters used in suchinhalation devices are designed to deliver a predetermined dose ofmedicament upon each actuation by means of an outlet valve member (e.g.,metering slide valve) at one end which can be opened either bydepressing the valve member while the canister is held stationary or bydepressing the canister while the valve member is held stationary. Inthe use of such devices, the aerosol canister is placed in the housingwith the outlet valve member of the canister communicating with themouthpiece. When used for dispensing medicaments, for example, inbronchodilation therapy, the patient holds the housing in a more or lessupright position and the mouthpiece of the inhalation device is placedin the mouth of the patient. The aerosol canister is manually actuatedto dispense a dose of medicament from the canister which is then inhaledby the patient.

It may be understood that effective delivery of medicament to thepatient using an inhalation device such as a conventional MDI is to anextent dependent on the patient's ability to manually actuate the device(e.g., discharging the aerosol) and to coordinate the actuation thereofwith the taking of a sufficiently strong inward breath. For somepatients, particularly young children, the elderly and the arthritic,manual actuation of the device can present difficulties. Other patientsfind it difficult to coordinate the taking of a reliable inward breathwith actuation of the device. Thus, there is a risk of not receiving anappropriate dose of medicament. Conventional manually actuated MDIs alsosuffer from a variety of other deficiencies and drawbacks, including,for example, the ability to actuate the device while not in a generallyupright position or without ensuring the medicament is sufficientlyagitated within the container prior to delivery.

BRIEF SUMMARY

Embodiments described herein provide aerosol delivery systems andrelated methods particularly suitable for delivering a dose ofaerosolized matter in an efficient and reliable manner for inhalation bya user. Embodiments include aerosol delivery systems featuringelectronically controlled, motor-driven actuation of an aerosol canisterwhich may be triggered by breath sensing techniques. Embodiments may beprovided in multi-part form factors featuring a base housing including amotor-driven actuator and other system components, and a removablecartridge insertably receivable in the base housing to form a completeaerosol delivery unit for selectively delivering a dose of aerosolizedmatter to the user. Advantageously, the removable cartridge may beconfigured to enable manual actuation of the aerosol canister whileremoved from the main housing similar to a conventional MDI whileproviding enhanced functionality when received in the main housing.

Embodiments of the electronically controlled, motor-driven, breathactuated aerosol delivery systems described herein may provide enhanceduser experience and may facilitate increased compliance by bothsimplifying the inhalation process and by providing targeted informationto the user. To do this the aerosol delivery systems automate primaryfunctions such as breath timing and canister actuation while also beinginstrumented to capture usage data which can be used to inform the useron correct inhalation technique. Information may be supplied to the useron board an aerosol delivery unit through a display screen, for example,through haptic and/or audible feedback and/or via an associatedapplication running on a paired smart phone or other computing devicewith which the aerosol delivery unit may communicate wirelessly.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a skewed isometric view showing a sequence in which aremovable cartridge containing an aerosol canister is inserted in a basehousing to form an aerosol delivery unit, according to one embodiment.

FIG. 2 is an enlarged partial cross-sectional view of the aerosoldelivery unit of FIG. 1 shown with a mouthpiece cover open to reveal anoutlet through which aerosolized matter is discharged for inhalation bya user.

FIG. 3A is an isometric view of an aerosol delivery unit, according toanother embodiment, which includes a removable cartridge coupled to abase housing.

FIG. 3B is an isometric view of the aerosol delivery unit of FIG. 3Awith the removable cartridge shown separated from the base housing.

FIG. 3C is an isometric view of the removable cartridge portion of theaerosol delivery unit of FIG. 3A, which shows a canister chassis portionwith an onboard power source separated from a mouthpiece subassembly.

FIG. 4 is an isometric cross-sectional view of the complete aerosoldelivery unit shown in FIG. 3A from one perspective.

FIG. 5 is an isometric cross-sectional view of the complete aerosoldelivery unit shown in FIG. 3A from another perspective.

FIG. 6 is an isometric view of a motor-driven actuator assembly of theaerosol delivery unit of FIG. 3A.

FIG. 7 is an isometric view of the motor-driven actuator assembly ofFIG. 6 with the casing partially removed to reveal internal componentsthereof.

FIG. 8 is diagram illustrating actuation of the aerosol canister via themotor-driven actuator assembly of FIGS. 6 and 7.

FIG. 9 is a cross-sectional view of the aerosol delivery unit of FIG. 3Ashowing a pressure sensor within the base housing which is incommunication with the inhalation passageway of the removable cartridgeto sense an inhalation event and trigger actuation of the canister.

FIG. 10 is a side elevational view showing an aerosol delivery unit,according to another embodiment, having separable portions.

FIG. 11 is a diagram illustrating a method of preparing the aerosoldelivery unit of FIG. 10 for use.

FIG. 12 is a diagram illustrating a method of using the aerosol deliveryunit of FIG. 10 to receive a dose of aerosolized matter.

FIG. 13 illustrates aerosol delivery units according to otherembodiments having different release mechanisms for releasing aremovable cartridge assembly from a base housing.

FIG. 14 is a schematic diagram of a control system suitable for use withembodiments of the aerosol delivery units disclosed herein.

FIGS. 15A-15C depict certain portions of a Graphical User Interface(GUI) that may be provided via a client device communicatively coupledto an aerosol delivery unit in accordance with techniques and featuresdescribed herein.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various disclosedembodiments. However, one of ordinary skill in the relevant art willrecognize that embodiments may be practiced without one or more of thesespecific details. In other instances, well-known structures and devicesassociated with MDIs or other inhaler devices or components may not beshown or described in detail to avoid unnecessarily obscuringdescriptions of the embodiments.

Unless the context requires otherwise, throughout the specification andclaims which follow, the word “comprise” and variations thereof, suchas, “comprises” and “comprising” are to be construed in an open,inclusive sense, that is as “including, but not limited to.”

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. Thus, the appearances of the phrases “in one embodiment” or“in an embodiment” in various places throughout this specification arenot necessarily all referring to the same embodiment. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more embodiments.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. It should also be noted that the term “or”is generally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

Embodiments described herein provide aerosol delivery systems andrelated methods particularly suitable for delivering a dose ofaerosolized matter in an efficient and reliable manner for inhalation bya user. Embodiments include aerosol delivery systems featuringelectronically controlled, motor-driven actuation of an aerosol canisterwhich may be triggered by breath sensing techniques. Embodiments may beprovided in multi-part form factors featuring a base housing includingthe motor-driven actuator and other system components, and a removablecartridge containing an aerosol canister which may be insertablyreceived in the base housing to form a complete aerosol delivery unitfor selectively delivering a dose of aerosolized matter (e.g.,medicament) to a user. Advantageously, the removable cartridge may beconfigured to enable manual actuation of the aerosol canister whenremoved from the main housing similar to a conventional MDI whileproviding enhanced functionality when received in the main housing.Other advantages will be appreciated from a detailed review of thepresent disclosure.

Although the aerosol delivery systems described herein are shown anddescribed in the context of electronically controlled, motor-driven,breath actuated metered dose inhaler systems for delivering medicamentor other aerosolized matter to a user, it will be appreciated by thoseof ordinary skill in the relevant art that features and aspects of suchsystems may applied to other devices and for other purposes.

FIG. 1 shows one example embodiment of an electronically controlled,motor-driven, breath actuated MDI in the form of an aerosol deliveryunit 10. The aerosol delivery unit 10 includes a base housing 12, whichincludes a majority of the system electronics as described in moredetail elsewhere, and a removable cartridge 14 that is removablycoupleable to the base housing 12 for selectively delivering a dose ofaerosolized matter (e.g., aerosolized medicament) to a user from anaerosol canister 16 carried by the removable cartridge 14.

With reference to FIG. 1, the example aerosol delivery unit 10 is afront loading device in which the removable cartridge 14 is insertablein the base housing 12 in a direction generally perpendicular to alongitudinal axis A₁ of the aerosol canister 16 carried by the removablecartridge 14, as indicated by the arrow labeled 20. The base housing 12may include a housing body 22 defining a cavity 24 within which theremovable cartridge 14 may be received. An access door 28 may berotatably coupled to the housing body 22 and may be movable between anopen position O and a closed position C. In the open positon O, thecavity 24 of the housing body 22 may be revealed for loading thecartridge 14 into the base housing 12, or for removing the cartridge 14from the base housing 12. In the closed position C, the access door 28may enclose the cartridge 14 within the cavity 24 of the base housing12. One or more locking features 30 (e.g., resilient locking tabs,detents, latches) may be provided for securing the access door 28 to thehousing body 22 in the closed position C, and one or more releasedevices 32 (e.g., push buttons) may be provided for releasing orunlocking the access door 28 such that it may move to the open positionO. In other instances, the access door 28 may be opened by manuallyovercoming a threshold resistive force provided by the one or morelocking features 30. In some instances, a bias member (e.g., torsionalspring) may be provided to urge the access door 28 toward the openposition O such that the access door 28 may move toward the openposition O without manual assistance upon actuation of the one or morerelease devices 32 or upon overcoming the threshold resistive force.

With continued reference to FIG. 1, the base housing 12 may furtherinclude a mouthpiece cover 34 that is rotatably coupled to the housingto move between an open position 36 and a closed position 38. In theopen positon 36, the cavity 24 of the housing body 22 may be revealedfor loading the cartridge 14 into the base housing 12 or for removingthe cartridge 14 from the base housing 12. In the closed position 38,the mouthpiece cover 34 may conceal a mouthpiece 15 of the cartridge 14received within the cavity 24 of the base housing 12. For this purpose,one or more locking features 40 (e.g., resilient locking tabs, detents,latches) may be provided for securing the mouthpiece cover 34 to thehousing body 22 in the closed position 38. In some instances, one ormore release devices (e.g., push buttons) may be provided for releasingor unlocking the mouthpiece cover 34 such that it may move to the openposition 36. In other instances, the mouthpiece cover 34 may be openedby manually overcoming a threshold resistive force provided by the oneor more locking features 40. In some instances, a bias member (e.g.,torsional spring) may be provided to urge the mouthpiece cover 34 towardthe open position 36 such that the mouthpiece cover 34 may move towardthe open position 36 without manual assistance upon actuation of the oneor more release devices or upon overcoming the threshold resistiveforce. The mouthpiece 15 may be removably coupled to the remainder ofthe removable cartridge 14 to facilitate cleaning or replacement of themouthpiece 15. In some instances, for example, a separate removablemouthpiece 15 may be press fit or friction fit onto a correspondingmouthpiece receiving portion of the removable cartridge 14.

FIG. 2 shows an enlarged cross-sectional portion of the aerosol deliveryunit 10 for additional clarity.

According to the example embodiment shown in FIGS. 1 and 2, the completeaerosol delivery unit 10 may provide a portable or handheld unit capableof selectively delivering a dose of aerosolized matter with enhancedfunctionality, as described in more detail elsewhere.

FIGS. 3A through 9 show another example embodiment of an electronicallycontrolled, motor-driven, breath actuated MDI in the form of an aerosoldelivery unit 210. The aerosol delivery unit 210 includes a base housing212, which includes a majority of the system electronics as described inmore detail elsewhere, and a removable cartridge 214 that is removablycoupleable to the base housing 212 for selectively delivering a dose ofaerosolized matter (e.g., aerosolized medicament) to a user from anaerosol canister 216 carried by the removable cartridge 214.

With reference to FIGS. 3A-3C, the example aerosol delivery unit 210 isa bottom loading device in which the removable cartridge 214 isinsertable in the base housing 212 in a direction generally parallel toa longitudinal axis A₂ of the aerosol canister 216 carried by theremovable cartridge 214, as indicated by the arrow labeled 220 in FIG.3B. The base housing 212 may include a housing body 222 defining acavity 224 within which the removable cartridge 214 may be insertablyreceived. The housing body 222 may be a multi-piece assembly including,for example, an outer housing or cover and an inner base chassis towhich other components may be attached. The aerosol delivery unit 210may include one or more locking features 230 (e.g., resilient lockingtabs, detents, latches) for securing the removable cartridge 214 to thebase housing 212. In addition, one or more release devices 231 (e.g.,push buttons) may be provided for releasing or unlocking the removablecartridge 214 from the base housing 212 such that it may be removed andreplaced as needed or desired. In other instances, the removablecartridge 214 may be removed by manually overcoming a thresholdresistive force provided by the one or more locking features. In someinstances, a bias member (e.g., leaf spring) may be provided to assistin driving the removable cartridge 214 away from the base housing 212upon actuation of the one or more release devices 231 or upon overcomingthe threshold resistive force.

With continued reference to FIGS. 3A-3C, the removable cartridge 214 mayfurther include a mouthpiece cover 234 that is rotatably coupled tosurrounding structures to move between an open position 236, as shown inFIGS. 3B and 3C, and a closed position 238, as shown in FIG. 3A. In theclosed position 238, the mouthpiece cover 234 conceals a mouthpiece 215of the cartridge 214. In the open position 236, the mouthpiece 215 isrevealed for use. For this purpose, one or more locking features (e.g.,resilient locking tabs, detents, latches) may be provided for securingthe mouthpiece cover 234 in the closed position 238. In some instances,one or more release devices (e.g., push buttons) may be provided forreleasing or unlocking the mouthpiece cover 234 such that it may move tothe open position 236. In other instances, the mouthpiece cover 234 maybe opened by manually overcoming a threshold resistive force provided bythe one or more locking features. In some instances, a bias member(e.g., torsional spring) may be provided to urge the mouthpiece cover234 toward the open position 236 such that the mouthpiece cover 234 maymove toward the open position 236 without manual assistance uponactuation of the one or more release devices or upon overcoming thethreshold resistive force. The mouthpiece 215 may be removably coupledto other portions of the removable cartridge 214 to facilitate cleaningor replacement of the mouthpiece 215. In some instances, for example, aseparate removable mouthpiece 215 may be press fit or friction fit ontoa corresponding mouthpiece receiving portion of the removable cartridge214.

Advantageously, when the mouthpiece cover 234 is in the open position236, the mouthpiece cover 234 may hinder or prevent a user frominadvertently covering unit intake apertures 312 (FIG. 9) provided atthe bottom of the aerosol delivery unit 210 for enabling air to enterthe unit 210 to assist in delivering the aerosolized matter.

With reference to FIG. 3C, the removable cartridge 214 may be providedin separable portions. For example, the removable cartridge 214 mayinclude a canister chassis 293 and a mouthpiece subassembly 295 that isconfigured to removably receive the canister chassis 293. The canisterchassis 293 is structured to accommodate, among other things, thecanister 216 and an onboard power source 320, as discussed in moredetail elsewhere. The mouthpiece assembly 295 includes, among otherthings, the mouthpiece 215 and a stem support 302 (FIGS. 4 and 5) forreceiving the valve stem 217 of the canister 216 and supporting thecanister 216 in fluid communication with the mouthpiece 215, asdiscussed in more detail elsewhere. The canister chassis 293 isremovably coupleable to the mouthpiece subassembly 295 to form a fullyfunctional, manually depressible cartridge that includes functionalitysimilar to that of a conventional manually depressible MDI. In thismanner, a user can optionally use the removable cartridge 214 as asuitable inhaler device without the added functionality provided whencoupling the removable cartridge 214 to the base housing 212. Thecanister chassis 293 may be removably coupleable to the mouthpiecesubassembly 295 via one or more fastening devices or techniques,including for example, one or more detent mechanisms 297 provided on thecanister chassis 293 that are arranged to engage corresponding features(not visible) of the mouthpiece subassembly 295.

FIGS. 4 and 5 provide cross-sectional views of the complete aerosoldelivery unit 210 from different viewpoints with the removable cartridge214 coupled to the base housing 212 so as to reveal various internalcomponents of the aerosol delivery unit 210 which are configured toprovide, among other functionality, electronically controlled,motor-driven, breath actuated, metered dose delivery of aerosolizedmatter to a user.

The base housing 212 is provided with, among other features, a controlsystem 250, including a main printed circuit board (PCB) 252 and a subPCB 253, and an actuator assembly 260 electronically coupled to the PCBs252, 253 for providing controlled actuation of the aerosol canister 216.Further details of the actuator assembly 260 are shown in FIGS. 6through 8. More particularly, FIGS. 6 and 7 show the actuator assembly260 isolated from all other system components for clarity and FIG. 8provides a diagram showing actuation of the aerosol canister 216 via theactuator assembly 260 between an expanded configuration E, in which avalve member of the aerosol canister 216 remains closed, and a depressedconfiguration D, in which the valve member of the aerosol canister 216transitions to an open position to release a metered dose of aerosolizedmatter.

With reference to FIGS. 6 and 7, the actuator assembly 260 includes anelectric motor 262 (e.g., DC electric motor), a gear train 264 a-264 d,a cam member 266 and a yoke 268 that is driven by the cam member 266 viathe electric motor 262 and the gear train 264 a-264 d. The electricmotor 262, the gear train 264 a-264 d, the cam member 266 and the yoke268 may be partially enclosed in a casing 170, as shown in FIGS. 6 and7, substantially enclosed in a casing, or fully enclosed in a casing.Bias members 272 in the form of compression springs are provided betweenthe yoke 268 and the casing 270 for urging the yoke 268 into contactwith the cam member 266 and providing mechanical assistance in movingthe aerosol canister 216 from the expanded configuration E to thedepressed configuration D as the cam member 266 is driven to rotateabout an axis of rotation R by the electric motor 262 and gear train 264a-264 d. The casing 270 may include a plurality of separate casingportions and may be coupled together by corresponding coupling features274 (e.g., snaps, detents, latches) to partially, substantially, orcompletely enclose the electric motor 262, the gear train 264 a-264 d,the cam member 266 and the yoke 268. The casing 270 includes at leastone opening through which a lower end 269 of the yoke 268 extends tocontact the aerosol canister 216 during actuation.

During actuation, the electric motor 262 is driven by the control system250 in response to a trigger signal to move the canister 216 through thesequence illustrated in FIG. 8 to compress and release the aerosolcanister 216 to discharge a dose of the aerosol matter for inhalation bya user. More particularly, as will be appreciated from a review of FIG.8, the cam member 266 is controlled to rotate in direct correlation withrotation of the electric motor 262 via the gear train 264 a-264 d and toride in a slot 267 of the yoke 268 and bear against the yoke 268 to urgethe yoke 268 downward into contact with the canister 216 during adownward stroke (i.e., valve opening stroke) to push the canister to thedepressed configuration D and to thereafter enable the yoke 268 to moveback upward during a return stroke (i.e., valve closing stroke) toenable the canister 216 to return to the expanded configuration E underthe force of an internal bias member (e.g., valve spring) of thecanister 216. In this manner, the position of the yoke 268 and hencecanister 216 may be precisely controlled by the electric motor 262 andother components of the control system 250.

With reference to FIGS. 6 and 7, the gear train 264 a-264 d may includea drive spur gear 264 a coupled directly to a drive shaft of theelectric motor 262, a driven spur gear 264 b meshed with the drive spurgear 264 a, a worm screw 264 c formed integrally with the driven spurgear 264 b to rotate in unison therewith, and a worm wheel 264 d meshedwith the worm screw 264 c. The worm screw 264 c and the worm wheel 264 dmay form a worm gear set or worm drive portion of the gear train 264a-264 d, and may include a 2 start worm. According to some embodiments,including the example embodiment of the actuator assembly 260 shown inFIGS. 6 and 7, the gear ratio of the driven spur gear 264 b and thedrive spur gear 264 a may be at least 2:1 and the worm drive maycomprise a 2 start worm with a gear ration of at least 20:1 to provideincreased torque for actuating the aerosol canister 216.

According to the illustrated embodiment, the worm screw 264 c has anaxis of rotation parallel to an axis of rotation of the electric motor262 and the worm wheel 264 d is meshed with the worm screw 264 c torotate perpendicular thereto. In some instances, the cam member 266 andthe worm wheel 264 d may be portions of the same unitary part such thata rotational position of the electric motor 262 controls the rotationalposition of the cam member 266 via the intermediary of the driven spurgear 264 b and the worm gear set 264 c, 264 d. During actuation, and aspreviously described, the cam member 266 rides in the slot 267 of theyoke 268 and bears against the yoke 268 to urge the yoke 268 downwardinto contact with the canister 216 during a downward stroke to move thecanister 216 into the depressed configuration D and to thereafter enablethe yoke 268 to move back upward during a return stroke to enable thecanister 216 to return to the expanded configuration E under the forceof an internal bias member of the canister 216.

More particularly, as the motor 262 drives in a forward direction, theyoke 268 moves linearly downward and depresses the canister 216. Sincethe canister valve stem 217 is fixed in the stem support 302 (FIGS. 4and 5), the valve stem 217 is compressed. The yoke 268 continues todepress the canister 216 until the motor 262 reaches its stall torque.The motor 262 may stall under three conditions: (i) the canister valvespring force balances the motor torque via the gear-train 264 a-264 d;(ii) the canister valve stem bottoms-out; or (iii) the worm-wheel 264 dreaches a forward end stop. In any of these cases, the system isdesigned such that the valve stem 217 will be compressed beyond itsfiring point before the stall torque is reached.

In order to prevent the motor 262 from wasting power and overheatingwhen it is stalled (e.g., due to the canister 216 reaching the end-stopduring actuation or due to the motor 262 otherwise reaching its stalltorque), the control system 250 may monitor feedback signals from themotor control electronics which exhibit distinct patterns when the motor262 is running or stalled. Once stall is detected, forward drive powerto the motor 262 is cut. The control system 250 may then wait for adwell-time sufficient to ensure that the matter delivered by through thevalve stem 217 has time to vaporize and enter the inhalation passageway296. The motor 262 is then driven in the reverse direction until itstalls on a worm-wheel home position end stop. A canister valve springcauses the canister 216 to return to its normal position, allowing themetering valve to refill in readiness for a subsequent dose.

Advantageously, in some embodiments, the entire gear train 264 a-264 d,the cam member 266 and the yoke 268 may be injection molded plasticcomponents and may be supported without separate bearings (e.g., rollerbearings). In this manner, the weight of the actuator assembly 260 maybe minimized and the complexity of the assembly reduced. Overall, theactuator assembly 260 shown in FIGS. 6 and 7 provides a particularlylightweight yet durable drive system for electronic controlled actuationof the aerosol canister 216, which is particularly advantageous forproviding a handheld or portable aerosol delivery unit 210.

With reference again to FIGS. 4 and 5, the actuator assembly 260 may beprovided in an upper portion of the base housing 212 to interface withan upper end of the aerosol canister 216 when the removable cartridge214 is installed for use. The casing 270 of the actuator assembly 60 mayinclude one or more coupling features 278 (FIG. 6) for engaging the basehousing 212 or a chassis thereof. The electric motor 262 of the actuatorassembly 260 is communicatively coupled to the PCBs 252, 253 of thecontrol system 250 for controlling motion of the electric motor 262 andhence actuation of the aerosol canister 216.

In some instances, the actuator assembly 260 may be controlled toactuate the aerosol canister 216 in response to a pressure signalarising from inhalation of a user via a mouthpiece 215 of the removablecartridge 214. For this purpose, the control system 250 may furtherinclude a pressure sensor 280 (e.g., a microelectromechanical systems(MEMS) pressure sensor) communicatively coupled to the main PCB 252. Insome instances, the pressure sensor 280 may be coupled directly to themain PCB 252 and may be positioned to interface with the removablecartridge 214 to sense a change in pressure within the removablecartridge 214 arising from inhalation by a user in order to triggeractuation of the aerosol canister 216. The pressure sensor 280 mayfurther include temperature sensing functionality or otherwise operatein conjunction with a separate temperature sensor to provide pressureand temperature data for calculating the air flow rate through the unit210 from which to trigger the actuation of the aerosol canister 216.

For instance, with reference to the enlarged cross-sectional view ofFIG. 2 from the example embodiment of the aerosol delivery unit 10 shownin FIG. 1, the removable cartridge 14 may include a cartridge body 90having a mouthpiece aperture 92 through which to inhale aerosolizedmatter released from the canister 16, one or more inhalation passagewayintake apertures or orifices 94 through which air can enter, and aninhalation passageway 96 extending from a location of the one or moreinhalation passageway intake apertures or orifices 94 to a location ofthe mouthpiece aperture 92, the inhalation passageway 96 being in fluidcommunication with a discharge outlet 98 of the aerosol canister 16.More particularly, the inhalation passageway 96 may be in fluidcommunication with the discharge outlet 98 of the aerosol canister 16via a discharge passageway 100 extending through a stem support 102 ofthe cartridge body 90 within which a stem 17 of the canister 16 isreceived. The discharge passageway 100 may terminate in an outlet 101that is generally aligned with the inhalation passageway 96 such thatthe discharged aerosolized matter may be effectively withdrawn from thecartridge 14 with the same inhalation breath that triggers its release.

The pressure sensor 80 may be arranged to detect pressure within theinhalation passageway 96 near the one or more inhalation passagewayintake apertures or orifices 94, with a change in the pressure beingindicative of one or more characteristics of a flow of air movingthrough the one or more inhalation passageway intake apertures ororifices 94. A compliant seal 104 may be positioned around the pressuresensor 80 to engage the removable cartridge 14 and provide a sealedpassageway 106 extending from the pressure sensor 80 toward theinhalation passageway 96 of the removable cartridge 14. In this manner,during inhalation, air may enter the inhalation passageway 96 onlythrough the one or more inhalation passageway intake apertures ororifices 94 to subsequently pass through the inhalation passageway 96wherein the aerosolized matter is mixed with the air stream andwithdrawn from the mouthpiece aperture 92 by the user.

With continued reference to FIG. 2, the cartridge body 90 may define atleast a majority of the inhalation passageway 96 and an orifice plate110 including the one or more inhalation passageway intake apertures ororifices 94 may be coupled to an intake end of the cartridge body 90. Ina particularly advantageous embodiment, the orifice plate 110 mayconsist of a respective orifice 94 positioned on each of opposing sidesof the aerosol delivery unit 10 and the pressure sensor 80 may belocated centrally between the orifices 94. As an example, the orificeplate 110 shown in FIG. 2 may be symmetrically formed about a centralplane bisecting the aerosol delivery unit 10 such that a respectiveorifice 94 is positioned on each of opposing sides of the aerosoldelivery unit 10, and the pressure sensor 80 may be located at or nearthe central plane. The orifices 94 may be the same size and maycollectively define or establish a relationship between the sensedpressure and one or more characteristics of a flow of air movingtherethrough from which to then control the release of the aerosolizedmatter. The size and shape of the orifices 94 may be determined inaccordance with the capabilities of the pressure sensor 80 to provide asuitable pressure profile throughout inhalation from which to determinewhen a threshold airflow is exceeded for controlling the delivery of theaerosolized matter.

Although the inhalation passageway intake apertures or orifices 94 ofthe illustrated embodiment include two relatively small apertures havinga circular cross-sectional profile and being positioned immediatelyadjacent a respective sidewall of the cartridge body 90 that defines theinhalation passageway 96, it is appreciated that the number, size, shapeand position of the inhalation passageway intake apertures or orifices94 may vary. For example, one, three, four or more inhalation passagewayintake orifices 94 may be provided and the orifice(s) may have an oblongor other regular or irregular cross-sectional shape. In addition,although the one or more inhalation passageway intake apertures ororifices 94 are shown as being provided in a separate orifice plate 110coupled to an intake end of the cartridge body 90, it is appreciatedthat in some instances the one or more intake apertures or orifices 94may be provided directly in the cartridge body 90. For example, in someembodiments, the orifice plate 110 may be an integral portion of thecartridge body 90, rather than a separate component. The housing body 22of the base housing 12 which surrounds the removable cartridge 14 duringmotor-driven, breath actuated use of the aerosol delivery unit 10 mayinclude one or more unit intake apertures 112 for enabling external airto infiltrate the housing body 22 before moving through the inhalationpassageway intake apertures or orifices 94 provided in the inhalationpassageway 96 of the removable cartridge 14, which, apart from theinhalation passageway intake apertures or orifices 94 and mouthpieceaperture 92, is otherwise sealed.

As another example, and with reference to the cross-sectional views ofFIGS. 4, 5 and 9 from the example embodiment of the aerosol unit 210 ofFIGS. 3A-3C, the removable cartridge 214 may include a cartridge body290 having a mouthpiece aperture through which to inhale aerosolizedmatter released from the canister 216, one or more inhalation passagewayintake apertures or orifices 294 through which air can enter, and aninhalation passageway 296 extending from a location of the one or moreinhalation passageway apertures or orifices 294 to a location of themouthpiece aperture 292, the inhalation passageway 296 being in fluidcommunication with a discharge outlet of the aerosol canister 216. Moreparticularly, with reference to FIGS. 4 and 5, the inhalation passageway296 may be in fluid communication with the discharge outlet of theaerosol canister 216 via a discharge passageway 300 extending through astem support 302 of the cartridge body 290 within which a stem 217 ofthe canister 216 is received. The discharge passageway 300 may terminatein an outlet 301 that is generally aligned with the inhalationpassageway 296 such that the discharged aerosolized matter may beeffectively withdrawn from the cartridge 214 with the same inhalationbreath that triggers its release.

With reference to FIG. 9, the pressure sensor 280 may be arranged todetect pressure within the inhalation passageway 296 in the vicinity ofthe one or more inhalation passageway intake apertures or orifices 294,with a change in the pressure being indicative of one or morecharacteristics of a flow of air moving through the one or moreinhalation passageway intake apertures or orifices 294. For thispurpose, a pressure sensing conduit 303 may extend through the unit 210from a vicinity of the one or more inhalation passageway intakeapertures 294 in the cartridge body 290 to the pressure sensor 280,which may be mounted on the main PCB 252 in the base housing 212. Inaddition, compliant seals 304, 305 may be positioned around the pressuresensor 280 and at an interface between a base housing portion of thepressure sensing conduit 303 and a removable cartridge portion of thepressure sensing conduit 303 to provide a sealed passageway 306 thatextends from the pressure sensor 280 toward the inhalation passageway296 within the removable cartridge 214. In this manner, duringinhalation, air may enter the inhalation passageway 296 only through theone or more inhalation passageway intake apertures or orifices 294 tosubsequently pass through the inhalation passageway 296 wherein theaerosolized matter is mixed with the air stream and withdrawn from themouthpiece aperture 292 by the user.

With continued reference to FIG. 9, the cartridge body 290 may define atleast a majority of the inhalation passageway 296 and the one or morecartridge intake apertures or orifices 294 may be formed in a floorportion 310 thereof. In a particularly advantageous embodiment, thecartridge body 290 may include a respective orifice 294 positioned oneach of opposing sides of the aerosol delivery unit 210, and moreparticularly on each of opposing sides of the stem support 302. Theorifices 294 may be the same size and may collectively define orestablish a relationship between the sensed pressure and one or morecharacteristics of a flow of air moving therethrough from which to thencontrol the release of the aerosolized matter. The size and shape of theorifices 294 may be determined in accordance with the capabilities ofthe pressure sensor 280 to provide a suitable pressure profilethroughout inhalation from which to determine when a threshold airflowis exceeded for controlling the delivery of the aerosolized matter.

Although the inhalation passageway apertures or orifices 294 of theillustrated embodiment include two relatively small apertures having acircular cross-sectional profile which are positioned on opposing sidesof the stem support 302, it is appreciated that the number, size, shapeand position of the cartridge intake apertures or orifices 294 may vary.For example, one, three, four or more intake orifices 294 may beprovided and the orifice(s) may have an oblong or other regular orirregular cross-sectional shape.

As shown in FIG. 9, the removable cartridge 214 of the aerosol deliveryunit 210 may include one or more unit intake apertures 312 (such as mayfrom an intake grate) for enabling external air to infiltrate a portionof the aerosol delivery unit 210 before moving through the inhalationpassageway intake apertures or orifices 294 provided in the inhalationpassageway 296, which, apart from the inhalation passageway intakeapertures or orifices 294 and mouthpiece aperture 292, is otherwisesealed.

With reference back to FIGS. 1 and 2, the removable cartridge 14 mayinclude the cartridge body 90 and one or more additional body portions,such as a cartridge cap 91, coupleable together to retain the aerosolcanister 16 and other components within the removable cartridge 14.Advantageously, the other components may include a power source 120having sufficient capacity to power an actuator assembly for depressingthe canister and other electronic components of the aerosol deliveryunit 10 throughout the usable life of the aerosol canister 16 (i.e.,until the aerosol canister 16 is depleted). In this manner, a new powersource 120 may be provided with each new removable cartridge 14 toensure sufficient power capacity to power the aerosol delivery unit 10without interruption. In other words, a new replacement cartridge 14 maybe supplied periodically with a new medicament canister 16 and a newpower source 120 (e.g., battery) to provide prolonged treatment in asafe and effective manner.

In some embodiments, the aerosol canister 16 and the power source 120may be accommodated in adjacent compartments of the removable cartridge14. In other embodiments, the aerosol canister 16 and the power source120 may be provided in the same compartment. In some instances, thepower source 120 may be shaped to conform around at least a portion ofthe canister 16 to provide additional space savings and to reduce theoverall form factor of the aerosol delivery unit 10.

The removable cartridge 14 may comprise electrical contacts (notvisible), such as on a rear end of the cartridge 14 for providing powerfrom the power source 120 carried onboard the cartridge 14 to theactuator assembly (not visible) and other system components provided inthe base housing 12 when the cartridge 14 is coupled to the base housing12 for use. A supplemental PCB (not visible) may be provided in theremovable cartridge 14 and may be in electrical communication with thepower source 120 and the aforementioned electrical contacts.

Although the removable cartridge 14 of the example embodiment of theaerosol delivery unit 10 shown in FIGS. 1 and 2 preferably includes anonboard power source 120 sufficient to power all electronic componentsof the aerosol delivery unit 10 throughout the usable life of thecartridge 14, in some instances the removable cartridge 14 may lack apower source altogether, or in other instances, may include a lowcapacity power source sufficient only to provide power for some limitedfunctionality, such as, for example, maintaining an accurate dose countassociated with the canister 16. In such instances, a suitable powersource, including a replaceable power source or rechargeable powersource, may be provided in or integrated with the base housing 12 andthe size of the removable cartridge 14 may be reduced to provide aparticularly slender or low profile cartridge. For embodiments featuringa rechargeable power source, a separate docking unit or station may beprovided for selectively charging the rechargeable power source withinthe base housing 12.

With reference to FIGS. 1 and 2, a dose counter arrangement, including adepressible carriage 122 and a counter switch (not visible), may beprovided within the removable cartridge 14 so as to count and track thenumber of doses administered and/or remaining in the removable cartridge14. The dose counter arrangement may be electrically coupled to thesupplemental PCB and a storage device (e.g., non-volatile memory)integrated in the supplemental PCB for storing dose information andoptionally communicating the dose information to other portions of acontrol system, including, for example, a main PCB provided in the basehousing 12. One or more additional switches may also be provided forensuring that a dose count is valid only when the system is properlyassembled. For example, a chassis 93 carrying the aerosol canister 16and the power source 120 may include a switch or operate in connectionwith a switch that is activated when the chassis 93 is properly seatedwithin the cartridge body 90 of the removable cartridge 14 with thevalve stem 17 of the canister properly engaging the stem support 102.

With continued reference to FIGS. 1 and 2, the base housing 12 mayfurther include a display screen 13 (e.g., LCD screen) electricallycoupled to the main PCB of the control system, such as, for example, bya flexible ribbon cable, for displaying information in connection withthe use of the aerosol delivery unit 10, including, for example, aremaining dose count reflecting the number of doses remaining in theaerosol canister 16 of the removable cartridge 14. The display screen 13may be powered by the power source 120 carried by the removablecartridge 14 and managed by a power management module located on themain PCB or other PCB component.

The control system may also include a wireless communication module(e.g., Bluetooth module), which may be integrated with the main PCB orother PCB component, for exchanging information with a remote device,such as, for example, a smart phone or other computing device. In thismanner, various data, including dose information, may be communicated tothe remote device for various purposes, as described in more detailelsewhere.

The base housing 12 may further include one or more external controldevices 130 (e.g., buttons, switches, touch controls) for controllingone or more ancillary functions. For example, in some embodiments, apush-button control may be provided for triggering a priming function inwhich the canister 16 is actuated at least once by the actuator assemblyprior to actuation of the canister 16 in response to breath actuation bythe user. In other embodiments, the base housing 12 may be completelydevoid of any external controls and the aerosol delivery unit 10 mayfunction entirely via spatial manipulation of the aerosol delivery unit10 and user-interaction with the mouthpiece 15.

With reference to the embodiment of the aerosol delivery unit shown inFIGS. 3A through 9, the removable cartridge 214 may include a canisterchassis 293 that is removably coupleable to a mouthpiece subassembly 295to, among other things, facilitate cleaning of the mouthpiecesubassembly 295, and in particular the inhalation passageway 296 and thedischarge passageway 300 which extends through the stem support 302.Furthermore, the canister chassis 293 may include a chassis body 307 andone or more additional body portions, such as a chassis cap 308,coupleable together to retain the aerosol canister 216 and othercomponents within the removable cartridge 214. Advantageously, the othercomponents may include a power source 320 having sufficient capacity topower the actuator assembly 260 and other electronic components of theaerosol delivery unit 210 throughout the usable life of the aerosolcanister 216 (i.e., until the aerosol canister 216 is depleted). In thismanner, a new power source 320 may be provided with each new removablecartridge 214 to ensure sufficient power capacity to power the aerosoldelivery unit 210 without interruption. Although the entire removablecartridge 214 may be replaced periodically with the aerosol canister216, it is appreciated that in some instances, only the canister chassis293 may be replaced with the canister 216 and the mouthpiece subassembly295 may be reused throughout the entire life cycle of the aerosoldelivery unit 210 (or for at least several canister replacement cycles).Still further, it is appreciated that in some embodiments the valve stemsupport 302 and associated discharge passageway 300 extendingtherethrough may be integrated into the canister chassis 293 (as opposedto the mouthpiece subassembly 295) such that a new discharge passageway300 may be provided when replacing the canister chassis 293 withoutreplacing the mouthpiece subassembly 295.

In some embodiments, the aerosol canister 216 and the power source 320may be accommodated in adjacent compartments of the canister chassis293. In other embodiments, the aerosol canister 216 and the power source320 may be provided in the same compartment. In some instances, thepower source 320 may be shaped to conform around at least a portion ofthe canister 216 to provide additional space savings and to reduce theoverall form factor of the aerosol delivery unit 210.

The removable cartridge 214 may comprise electrical contacts 219 (notvisible), such as on a rear facing end of the cartridge 214 forproviding power from the power source 320 carried onboard the cartridge214 to the actuator assembly 260 and other system components provided inthe base housing 212 when the cartridge 214 is coupled to the basehousing 212 for use. A supplemental PCB 255 (FIGS. 4 and 5) may beprovided in the removable cartridge 214 and may be in electricalcommunication with the power source 320 and the aforementionedelectrical contacts.

Although the removable cartridge 214 of the example embodiment of theaerosol delivery unit 210 shown in FIGS. 3A through 9 preferablyincludes an onboard power source 320 sufficient to power all electroniccomponents of the aerosol delivery unit 210 throughout the usable lifeof the cartridge 214, in some instances the removable cartridge 214 maylack a power source altogether, or in other instances, may include a lowcapacity power source sufficient only to provide power for some limitedfunctionality, such as, for example, maintaining an accurate dose countassociated with the canister 216. In such instances, a suitable powersource, including a replaceable power source or rechargeable powersource, may be provided in or integrated with the base housing 212 andthe size of the removable cartridge 214 may be reduced to provide aparticularly slender or low profile cartridge. For embodiments featuringa rechargeable power source, a separate docking unit or station may beprovided for selectively charging the rechargeable power source withinthe base housing 212.

A dose counter arrangement, including a depressible carriage and acounter switch, may be provided within the removable cartridge 214 so asto count and track the number of doses administered and/or remaining inthe removable cartridge 214. The dose counter arrangement may beelectrically coupled to the supplemental PCB 255 and a storage device(e.g., non-volatile memory) integrated in the supplemental PCB 255 forstoring dose information and optionally communicating the doseinformation to other portions of the control system 250, including, forexample, the PCBs 252,253 provided in the base housing 212. One or moreadditional switches may also be provided for ensuring that a dose countis valid only when the system is properly assembled. For example, thecanister chassis 293 carrying the aerosol canister 216 and the powersource 320 may include a switch or operate in connection with a switchthat is activated when the canister chassis 293 is properly seatedwithin the mouthpiece subassembly 295 of the removable cartridge 214with the valve stem 217 of the canister properly engaging the stemsupport 302. For example, as shown in FIG. 3C, the canister chassis 293may include a deformable portion 298 which is configured to deforminwardly as the canister chassis 293 is properly seated in themouthpiece subassembly 295 to contact a switch that provides a signalindicative of a properly assembled cartridge 214. Certain functionalitymay be disabled in the absence of such a signal.

With reference to FIGS. 3A through 5, the base housing 212 may furtherinclude a display screen 213 (e.g., LCD screen) electrically coupled tothe main PCB 152, such as, for example, by a flexible ribbon cable, fordisplaying information in connection with the use of the aerosoldelivery unit 210, including, for example, a remaining dose countreflecting the number of doses remaining in the aerosol canister 216 ofthe removable cartridge 214. The display screen 213 may be powered bythe power source 320 carried by the removable cartridge 214 and managedby a power management module located on the main PCB 252 or the sub PCB253.

The control system 250 may also include a wireless communication module(e.g., Bluetooth module), which may be integrated with the main PCB 252or the sub PCB253, for exchanging information with a remote device, suchas, for example, a smart phone or other computing device. In thismanner, various data, including dose information, may be communicated tothe remote device for various purposes, as described in more detailelsewhere.

FIG. 10 shows another example of an electronically controlled,motor-driven, breath actuated metered dose inhaler system in the form ofa handheld aerosol delivery unit 410. The example aerosol delivery unit410 is a bottom loading device in which a removable cartridge assembly414 is insertably receivable in a base housing 412 in a directiongenerally parallel to a longitudinal axis of an aerosol canister 416carried by the removable cartridge assembly 414. The base housing 412may include a housing body 422 defining a cavity 424 within which theremovable cartridge assembly 414 may be received. The removablecartridge assembly 414 may comprise a canister chassis 417 thataccommodates the canister 416 and a power source 440, and a mouthpiecesubassembly 418 that is separable from the chassis 417, the mouthpiecesubassembly 418 including a mouthpiece 415 and a cartridge body 430having a mouthpiece aperture 432, one or more intake apertures 436, andan inhalation passageway 434 extending between the mouthpiece aperture432 and the one or more intake apertures 436 that is in fluidcommunication with a discharge outlet 438 of the canister 416 when theremovable cartridge assembly 414 is assembled. A mouthpiece cap 426 isprovided for selectively revealing and concealing the mouthpiece 415.The base housing 412 may further include a control system 450, includinga motor-driven actuation assembly 460, similar to the control system 250of the embodiment shown in FIGS. 3A through 9. Likewise, the removablecartridge assembly 414 defined by the combination of the canisterchassis 417 and the mouthpiece subassembly 418 may include the same orsimilar features of the removable cartridge 214 of the embodiment shownin FIGS. 3A through 9.

FIG. 11 provides a diagram illustrating a method of preparing theaerosol delivery unit 410 for use. The method may begin by shaking oragitating the removable cartridge 414 to prepare the medicament or othermatter in the canister 416 for delivery. The method may continue byopening the mouthpiece cap 426 and manually depressing the canister 416to dispense a dose of aerosolized matter and effectively prime the unit410 for subsequent use. A user may then insert the removable cartridge414 into the base housing 412 for subsequent electronically controlled,motor-driven, breath actuated metered dose delivery of the aerosolizedmatter. Advantageously, assembling the removable cartridge 414 and thebase housing 412 together may automatically initiate pairingfunctionality to connect the aerosol delivery unit 410 wirelessly to anassociated smart phone or other computing device.

FIG. 12 provides a diagram illustrating a method of using the aerosoldelivery unit 410 to receive a dose of aerosolized matter. The methodmay begin by shaking or agitating the delivery unit 410 to prepare themedicament or other matter in the canister 416 for delivery. A user maythen open the mouthpiece cap 426 and inhale on the mouthpiece 415 totrigger the control system 450 to drive the actuator assembly 460 toactuate the canister 416 and deliver a first dose of the aerosolizedmatter during the inhalation. The user may then pause for a shortduration (e.g., 30-60 seconds) and repeat the agitation and inhalationsteps to receive a second dose of the aerosolized matter. The mouthpiececap 426 may then be closed and the delivery unit 410 stored for futureuse.

FIG. 13 illustrates additional example embodiments of electronicallycontrolled, motor-driven, breath actuated metered dose inhaler systemsin the form aerosol delivery units each having a removable cartridgeassembly selectively releasable from a base housing. As shown, theremovable cartridge assembly may be selectively releasable via one ormore depressible buttons, manipulable levers or other releasemechanisms. More particularly, aerosol delivery unit A illustrates therelease of the removable cartridge assembly from the base housing bydepressing buttons located on opposing sides of the aerosol deliveryunit. Aerosol delivery unit B illustrates the release of the removablecartridge assembly from the base housing by lifting a manipulable leverprovided on the back of the aerosol delivery unit. Aerosol delivery unitC illustrates the release of the removable cartridge assembly from thebase housing by depressing a single button located on the back of theaerosol delivery unit. Other embodiments may include one or more releasemechanisms (buttons, levers, etc.) at other locations, such as, forexample, the bottom of the aerosol delivery unit. In other instances,the removable cartridge assembly may be separated from the base housingby simply overcoming a threshold force, such as, for example, may beprovided by friction fitted components, detents or other couplingdevices. In any event, the removable cartridge assembly may be readilyremovable from the base housing to facilitate, among other things,replacement of the removable cartridge assembly, cleaning of cartridgecomponents, and/or manual actuation of the canister that is carried bythe removable cartridge assembly.

Although embodiments of the aerosol delivery units 10, 210, 410 aredepicted herein as front cartridge loading and bottom cartridge loadingdevices, it is appreciated that a removable cartridge containing, amongother things, a canister of matter to be discharged and an associateddischarge passageway, may be configured to mate with a base housingcontaining, among other things, a actuator for firing the canister, fromany direction, including, for example, front, bottom, rear and sidedirections.

Additional features and functionality will now be described withreference to FIG. 14. FIG. 14 schematically depicts a control system1000 suitable for use with certain embodiments of the aerosol deliveryunits 10, 210, 410 disclosed herein. In particular, the control system1000 includes a resident control portion 1002 of an aerosol deliveryunit; a mouthpiece control portion 1004; and a consumable cartridgecontrol portion 1006.

In the depicted embodiment, the resident control portion 1002 includesone or more microprocessors 1010 that includes or is communicativelycoupled to one or more transmitters (such as a low-energy Bluetoothradio transmitter). In other embodiments, the microprocessor may includeor be communicatively coupled to additional transmitter types, or mayomit such transmitter. As depicted, the one or more microprocessors 1010are communicatively coupled to a power management module 1012; one ormore memories 1014, such as may store various information and/orprocessor-executable instructions related to operations of the controlsystem 1000; one or more antennas 1016; a vibration motor 1018, such asmay provide vibratory or other tactile feedback for users of theassociated aerosol delivery unit; an audio buzzer 1020, such as mayprovide audio feedback for users of the associated aerosol deliveryunit; a user-selectable priming button 1022, such as may allow a user ofthe associated aerosol delivery unit to manually trigger a primingfunction; a display 1024, such as to provide visual information orfeedback to a user of the aerosol delivery unit; one or moreaccelerometers 1026, such as may provide data signals to themicroprocessor 1010 indicative of an orientation or motion of theaerosol delivery unit; an actuator 1028 for selectively actuating thecanister 1050, and a pressure sensor 1030 for sensing air flow arisingfrom inhalation by a user from which to trigger actuation of thecanister 1050.

The mouthpiece control portion 1004 includes a mouthpiece cover sensor1032 communicatively coupled to the one or more microprocessors 1010,and mouthpiece cover 1034, which may be functionally analogous tomouthpiece cover 34 of the example aerosol delivery unit 10 shown inFIG. 1, the mouthpiece cover 234 shown in FIGS. 3A-3C, or the mouthpiececover 426 shown in FIG. 10.

In the depicted embodiment of FIG. 14, the control system 1000 includesa consumable cartridge control portion 1006 that is removably interfacedwith the resident control portion 1002. The consumable cartridge controlportion 1006 includes a consumable canister 1050 containing matter (notshown) to be aerosolized; a power source 1052 (which may be functionallyanalogous to the power source 120 of the example aerosol delivery unit10 shown in FIGS. 1 and 2, or the power source 320 of the aerosoldelivery unit 210 shown in FIGS. 3A through 9)) interfaced with thepower management module 1012 of the resident control portion; a dosagequantification or “puff count” chip 1054, which may locally (withrespect to the consumable cartridge) track and store informationregarding doses of matter expended or remaining within the consumablecanister, and is removably interfaced with the one or moremicroprocessors 1010; and one or more “puff count” contacts 1056 thatelectromechanically provide signals to the communicatively coupleddosage quantification chip.

In accordance with the control system 1000 of FIG. 14, embodiments mayenhance compliance with a dosing regimen by simplifying the inhalationprocess, providing additional safeguards against improper use of theaerosol delivery unit, and/or by providing targeted information to theuser. For example, the control system 1000 may be configured to senseshaking or agitation of the aerosol delivery unit in a period beforeattempted use via the one or more accelerometers 1026 (or other sensors)and temporarily prevent actuation of the canister 1050 by the actuator1028 if it is determined that sufficient shaking or agitation has notoccurred. The control system 1000 may also provide an indication (e.g.,haptic, audible or visual signal) to the user that additional shaking oragitation is required prior to release of the aerosolized matter. Asanother example, the control system 1000 may be configured to sense anorientation of the aerosol delivery unit in a period before attempteduse via the one or more accelerometers 1026 (or other sensors) andtemporarily prevent actuation of the canister 1050 by the actuator 1028if it is determined that the canister 1050 is not properly oriented fordelivery of the aerosolized matter (e.g., the aerosol delivery unit ishorizontal). The control system 1000 may also provide an indication(e.g., haptic, audible or visual signal) to the user that the aerosoldelivery unit must be reoriented to a more vertical position prior torelease of the aerosolized matter. Other safeguards may includepreventing actuation of the canister 1050 in situations where it isdetermined that the aerosol delivery unit is not properly assembled,such as, for example, when a removable cartridge carrying the canister1050 is not properly seated in a base housing comprising the residentcontrol portion 1002. These and other safeguards may collectivelyenhance compliance with a dosing regimen and help ensure that a userreceives a proper dose or medicament or other matter.

Various example graphical user interface (“GUI”) screens are nowpresented with respect to particular embodiments shown for illustrativepurposes, although it will be appreciated that other embodiments mayinclude more and/or less information, and that various types ofillustrated information may be replaced with other information.

FIGS. 15A-15C depict portions of a Graphical User Interface (GUI) 1100that may be provided as part of an aerosol delivery system interface toenable various user interactions with a client electronic device thatmay be, at various times, communicatively coupled to an aerosol deliveryunit according to one illustrated embodiment. As depicted, the GUI 1100is provided by a software application program (or “app”) executing onthe client electronic device. As used herein, such a client electronicdevice may be fixed or mobile, and may include instances of variouscomputing devices such as, without limitation, desktop or othercomputers (e.g., tablets, slates, etc.), network devices, smart phonesand other cell phones, consumer electronics, digital music playerdevices, handheld gaming devices, PDAs, pagers, electronic organizers,Internet appliances, television-based systems (e.g., using set-top boxesand/or personal/digital video recorders), and various other consumerproducts that include appropriate communication capabilities. In atleast some embodiments, the client electronic device may becommunicatively coupled to the aerosol delivery unit via a wireless datatransport interface of the client electronic device, such as a pairedBluetooth connection, wireless network connection, or other suitableconnection.

In the illustrated examples of FIGS. 15A-15C, the GUI interface 1100includes particular display portions and user-selectable controls thatmay be presented to user to enable the user to select and define variousmanners by which client electronic device displays information andinteracts with the user's aerosol delivery unit.

In particular, FIG. 15A presents an aerosolized matter identifier 1102,indicating that the matter contained within the consumable canistercurrently interfaced with the aerosol delivery unit is identified as“Symbicort”; aerosol delivery unit identifier 1104 (“Symbicort Device ID2”); graphical indicator 1106, providing a visual indication as to aquantity of doses or “puffs” of aerosolized matter remaining within thecurrent consumable canister, along with an indication of the relativepercentage of such matter as compared to the total capacity of theconsumable canister; time indicator 1108, providing a visual indicationof the time elapsed since the most recent prior use of the aerosoldelivery unit; user-selectable tab controls 1110 a-d, allowing a user toaccess different portions of functionality provided by the aerosoldelivery interface system and GUI 1100; and user-selectable assistancecontrol 1112, providing access to one or more instructional pagesregarding the GUI 1100 and/or aerosol delivery unit.

FIG. 15B presents various historical tracking information, such as ifthe user selected tab control 1110 b of FIG. 15A. In certainembodiments, such information may be generated by the client electronicdevice based on aerosol delivery data provided by the control system ofthe communicatively coupled aerosol delivery unit, such as controlsystem 1000 of FIG. 14. In the depicted embodiment of FIG. 15B, the GUI1100 includes user-selectable chronology controls 1116, enabling theuser to select the particular span of time (“1 week,” “1 month,” or “1year,” respectively) for which historical tracking information ispresented; graphical display portion 1118; usage indicator 1120,providing an indication of a quantity and percentage usage of theaerosol delivery unit during the selected time span; dosage informationentries 1122 a, providing information about individual doses consumed bythe user during the selected time span; and message indicator 1124,indicating that one or more notifications have yet to be reviewed by theuser.

Each of the dosage information entries 1122 indicates a date and time atwhich the respective dose was delivered via the aerosol delivery unit,as well as whether such dose consisted of a single “puff” or a secondsuch inhalation. In addition, in various embodiments the dosageinformation entries may provide certain other visual indicia ofinformation associated with the particular dosage entry. For example,dosage information entry 1122 a includes a flag indicator to denote thatonly a single inhalation was utilized for that respective dose as wellas a user-selectable “+” control to allow the user to view additionalinformation related to the respective dose. Similarly, dosageinformation entry 1122 b provides a user-selectable message control,allowing the user to view textual information associated with the entry.

In certain embodiments, the aerosol delivery system interface and/or GUI1100 may allow the user to select and configure one or more reminders,alerts, or other notifications based on data provided by thecommunicatively coupled aerosol delivery unit and its associated controlsystem. For example, the user may configure the system interface toprovide a reminder within a predetermined time of a scheduled dose; toprovide an alert when the user has failed to inhale a dose within apredetermined duration from the last administered dose; to provide oneor more notifications regarding a quantity of doses remaining in thecurrently interfaced consumable canister, such as if a thresholdquantity has been exceeded; etc. In at least some embodiments, the usermay configure the aerosol delivery system interface to provide suchnotifications or alerts to other users, such as providing a “shared”notification to one or more family members or medical professionalsassociated with the user.

FIG. 15C presents shared notification information as part of a Settingscontrol portion, such as if the user selected tab control 1110 d of FIG.15A. In the depicted embodiment, the GUI 1100 includes notification typecontrols 1130 and 1132, indicating notification types currentlyconfigured by the user; user-selectable “Add Notification” control 1134,allowing the user to configure additional notification types related tothe aerosol delivery unit and aerosol delivery system interface; anduser contact control 1136, allowing the user to specify particularcontacts to which particular notifications are to be provided by theaerosol delivery system interface.

In the illustrated example of FIG. 15C, the user has configured twotypes of notifications. The first notification type 1130 indicates thatif the user misses a scheduled dose, the aerosol delivery systeminterface will provide a notification to “Mom” and “Dr. Smith” via textmessage (as indicated by the highlighted smartphone icon). The secondnotification type 1132 indicates that upon certain criteria being metregarding the need to refill a prescription (such as if the currentlyinterfaced consumable canister contains less than a predefined quantityof remaining doses, or other configured criteria), the aerosol deliverysystem interface will provide a notification to “Mom” via email message(as indicated by the highlighted envelope icon). In this and otherembodiments, the GUI 1100 may allow the user to configure various othernotifications and alerts based on various criteria. For example, suchnotifications and alerts may be provided at regular time intervals,based on data provided by the aerosol delivery unit, based oninformation from one or more medical databases (such as if thepersonalized matter contained within the currently interfaced consumablecartridge passes an expiration date), or based on other informationand/or defined criteria.

It will be appreciated that the GUIs, display screens and otherinformation presented with respect to FIGS. 15A-15C are included forillustrative purposes, and that such information and/or otherinformation and associated functionality may be presented or otherwiseprovided in other manners in other embodiments. In addition, it will beappreciated that GUIs and other information presented to users may varywith the type of client device used by the user, such as to present lessinformation and/or functionality via client devices with smaller displayscreens and/or less ability to present information to or obtain inputfrom the user, such as under control of a mobile application of theaerosol delivery system interface executing on the client device, orotherwise based on information sent to the client device from theaerosol delivery system.

Although aspects of the embodiments have been described above inconnection with a consumable cartridge control portion, it will beappreciated that in some embodiments, the cartridge control portion, orparts thereof, may be non-consumable or durable. In some embodiments,for example, only the canister itself may be consumable while theremovable cartridge that accommodates the canister is reusablethroughout the life of the aerosol delivery unit.

In accordance with the systems described above, an example methodimplemented by a processor-based electronic client device may besummarized as including: receiving, by the processor-based electronicclient device while communicatively coupled to an aerosol delivery unitand via one or more electronic communications sent over a wirelessinterface of the electronic client device, aerosol delivery data fromthe aerosol delivery device, the aerosol delivery data being related toone or more user interactions with the aerosol delivery unit;generating, by the processor-based electronic client device and based atleast in part on the received aerosol delivery information, aerosoldelivery tracking information regarding the one or more userinteractions; and providing, via the processor-based electronic clientdevice, one or more indications regarding at least one of the aerosoldelivery tracking information and the aerosol delivery data.

In some instances, providing one or more indications to the user mayinclude displaying, via a user interface of the electronic clientdevice: one or more error messages related to the motion or theorientation of a canister interfaced with the aerosol delivery unit; anindication of estimated battery power remaining to the aerosol deliveryunit; one or more reminder notifications regarding a scheduled dose ofmatter; and/or instructional information regarding use of the aerosoldelivery unit. In addition to or in lieu of such displaying on theelectronic client device, one or more error messages, indication ofbattery power remaining and/or instructional use information maylikewise be displayed on a screen or other display device of the aerosoldelivery unit itself.

In some instances, receiving aerosol delivery data from the aerosoldelivery unit may include receiving at least one of a group thatincludes: data indicative of a motion or orientation of a canisterinterfaced with the aerosol delivery unit; data identifying mattercontained in the canister; data indicative of a quantity of matterremaining in the canister; data indicative of a quantity of matterexpended from the canister; data indicative of a number of doses ofmatter expended from the canister; and data indicative of a number ofdoses of matter remaining in the canister.

In some instances, receiving aerosol delivery data from the aerosoldelivery unit may include receiving data indicative of a quantity ofdoses of matter expended from the canister, and generating the aerosoldelivery tracking information may includes generating a quantity ofdoses of matter remaining in the canister. In some instances, generatingthe aerosol delivery tracking information may include generating dosagehistory information for a user associated with the processor-basedelectronic client device. Generating the dosage history information mayinclude generating dosage history information based at least in part onone or more canisters previously interfaced with the aerosol deliveryunit.

In some instances, the processor-based electronic client device may beassociated with a first user, and providing one or more indications mayinclude providing one or more notifications to one or more distinctother users regarding the first user's interactions with the aerosoldelivery unit.

In accordance with aspects of the embodiments of the aerosol deliveryunits disclosed herein, an aerosol delivery system for selectivelydelivering a dose of aerosolized matter may be summarized as including:an aerosol delivery unit configured to receive a canister containing thematter to be aerosolized; one or more accelerometers; one or moreprocessors; and at least one memory, the memory including instructionsthat, upon execution by at least one of the one or more processors,cause the aerosol delivery system to provide, via a user interface of aclient device associated with a user of the aerosol delivery unit, oneor more indications of information related to a canister interfaced withthe aerosol delivery unit. The information may include, for example, atleast one of a group that includes: a motion or orientation of thecanister; a quantity of matter remaining in the canister, a quantity ofmatter expended from the canister, a number of doses of matter expendedfrom the canister, and an estimated number of doses of matter remainingin the canister. The indicated information may further include one ormore identifiers associated with matter contained in the canister.

In some instances, the instructions may further cause the associatedclient device or a display of the aerosol delivery unit to display oneor more error messages related to the motion or the orientation of thecanister; an indication of estimated battery power remaining to theaerosol delivery unit; one or more reminder notifications regarding ascheduled dose of matter; and/or instructional information regarding useof the aerosol delivery unit. Other features and functionality will bereadily apparent by one of ordinary skill in the relevant art uponreviewing the present disclosure.

Moreover, aspects and features of the various embodiments describedabove may be combined to provide further embodiments. These and otherchanges can be made to the embodiments in light of the above-detaileddescription. In general, in the following claims, the terms used shouldnot be construed to limit the claims to the specific embodimentsdisclosed in the specification and the claims, but should be construedto include all possible embodiments along with the full scope ofequivalents to which such claims are entitled.

This application claims priority to U.S. Provisional Application No.62/194,701, filed Jul. 20, 2015, and U.S. Provisional Application No.62/212,379, filed Aug. 31, 2015, which applications are incorporatedherein by reference in their entireties.

The invention claimed is:
 1. An aerosol delivery unit for selectivelydelivering a dose of aerosolized matter, the aerosol delivery unitcomprising: a base housing; an actuator assembly provided in the basehousing; and a removable cartridge assembly coupled to the base housingand interfacing with the actuator assembly, the removable cartridgeassembly including: a canister containing matter to be aerosolized; anda cartridge unit within which the canister is loaded, the cartridge unitincluding a cartridge body having a mouthpiece aperture through which toinhale the dose of aerosolized matter released from the canister, one ormore intake apertures through which air can enter the cartridge unit,and an inhalation passageway extending from a location of the one ormore intake apertures to a location of the mouthpiece aperture and beingin fluid communication with a discharge outlet of the canister, and thecartridge unit further including a power source carried by the cartridgebody for powering the actuator assembly provided in the base housingadjacent the removable cartridge assembly, and wherein the cartridgeunit comprises a chassis that accommodates the canister and the powersource, and a mouthpiece subassembly that is separable from the chassis,the mouthpiece subassembly including the cartridge body having themouthpiece aperture, the one or more inhalation passageway intakeapertures, and the inhalation passageway.
 2. The aerosol delivery unitof claim 1 wherein the base housing includes an electronic display fromwhich to display information pertaining to the delivery of theaerosolized matter, the display being powered by the power source of theremovable cartridge assembly.
 3. The aerosol delivery unit of claim 1wherein a pressure sensor is provided within the base housing andarranged to detect pressure within the inhalation passageway of thecartridge body of the removable cartridge assembly, and wherein thepressure sensor is supported by a printed circuit board powered by thepower source of the removable cartridge assembly.
 4. The aerosoldelivery unit of claim 1 wherein a wireless communication device isprovided within the base housing to transmit information pertaining tothe delivery of the aerosolized matter, the wireless communicationdevice being powered by the power source of the removable cartridgeassembly.
 5. The aerosol delivery unit of claim 1 wherein a cavity ofthe base housing is sized and shaped to receive the removable cartridgeassembly in a front loading direction or a bottom loading direction. 6.The aerosol delivery unit of claim 1 wherein the removable cartridgeassembly is selectively releasable from the base housing via one or moreuser accessible release mechanisms.
 7. The aerosol delivery unit ofclaim 1 wherein the cartridge unit comprises electrical contacts forinterfacing with a control system of the base housing and providingpower from the power source onboard the cartridge unit to the actuatorassembly provided in the base housing.
 8. The aerosol delivery unit ofclaim 1 wherein the cartridge unit further comprises a dose countingarrangement enclosed within the chassis that accommodates the canisterand the power source.
 9. The aerosol delivery unit of claim 1 whereinthe cartridge unit includes a switch device arranged to generate anindication when the chassis that accommodates the canister and the powersource is properly coupled to the mouthpiece subassembly.